MAUDE Adverse Event Report: COOK INC FROVA INTUBATING INTRODUCER; LRC CHANGER, TUBE, ENDOTRACHEAL

Model Number N/A

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

Customer (person): (b)(6).Pma/510(k) #: exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that a frova intubating introducer broke prior to use.The device was to be used to intubate a patient, but did not make patient contact.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Correction- the summary report designation is incorrect; the report is not a summary report.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation.It was reported by mr.Ma immaduddin from hospital sultan abdul halim that a 8 french frova intubating introducer broke prior to intubating patient.The event date was reported to be a "few years back" and details could not be recalled.A complaint device was not returned.A review of the complaint history, instructions for use (ifu), and quality control of the device was conducted during the investigation.Additionally, a document based investigation evaluation was performed.A review of the device history and search for additional complaints on the same lot could not be carried out as the lot number is unknown.A review of device specifications was performed including quality control procedures.Cook has concluded that sufficient inspection activities are in place to assure functionality and device integrity prior to shipping.A complaint device was not returned, and lot information is unavailable.Therefore, no physical examinations could be performed.The evidence from the complaint file and quality control documents indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.The device is supplied with instructions for use which notes: the air exchange catheter is currently supplied with ifu c_t_cae_rev6.Pdf which includes the following intended use the cook airway exchange catheter is intended for uncomplicated, atraumatic endotracheal tube exchange.Warnings attention should be paid to insertion depth of the catheter into patient`s airway and correct tracheal position of replacement endotracheal tube catheter and endotracheal tube should not be advanced beyond the carina.-ensure proper sizing of the cook airway exchange catheter within a double-lumen endotracheal tube.Failure to do so may cause small fragments to be shave off during removal of the cook airway exchange catheter.Precautions.Standard techniques for placement and exchange of endotracheal tube should be employed.Endotracheal tube exchange 7.Remove the cae catheter and inflate the balloon cuff of the new endotracheal tube.Confirm its position using standard methods (e.G.Capnography, breath sounds and chest x-ray).Based on the information provided, no returned product and the results of the investigation, a definitive cause could not be established.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: FROVA INTUBATING INTRODUCER
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11414622
• MDR Text Key: 241561519
• Report Number: 1820334-2021-00884
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-8.0-35-FII
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/04/2021
• Supplement Dates Manufacturer Received: 04/05/2021; 06/16/2021
• Supplement Dates FDA Received: 04/16/2021; 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1